BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    PMA: P930027 · Supplement: S001 · Decision Jul 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37

    Basic Information

    Device Name
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
    Trade Name
    IMMULITE(R) THIRD GENERATION PSA
    PMA Number
    P930027
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    LTJ
    Generic Name
    PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 1996
    Date Received
    October 18, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE COAT-A-COUNT PSA IRMA FROM AN IMMUNORADIOMETRIC TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM TO A SOLID PHASE, TWO-SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY FOR USE ON THE IMMULITE AUTMOATED IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE PSA

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers